Gastrointestinal Neoplasm
Conditions
Brief summary
To evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes is not inferior to the similar products produced by Johnson & Johnson when the Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis
Detailed description
In this clinical trial, prospective, multi-center, stratified group randomization, incomplete blind setting, parallel positive control and non-inferiority test were used to evaluate the Disposable Powered Articulating Endoscopic Linear Cutter Stapler manufactured by Jiangsu Fengh Medical Co., Ltd. when used for gastrointestinal tissue cutting and anastomosis. To determine whether there is any difference in the incidence of adverse events, serious adverse events, device defects and other safety evaluation indicators compared with similar products produced by Johnson & Johnson.
Interventions
Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment
Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment
Sponsors
Fengh Medical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A test method in which subjects are not told whether they are a trial device or a control device in order to control intentional or unintentional bias in the course of a clinical trial and in the interpretation of results
Intervention model description
Patients randomized to the trial group and the control group will not cross use the product
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The subjects are 18 \ 75 years old, regardless of gender: 2. Subjects need to use a linear stapler for gastrointestinal tissue cutting and anastomosis: 3. The subject or his legal representative can understand the purpose of the study and show sufficient compliance with the study protocol And sign informed consent.
Exclusion criteria
1. The subject plans to perform emergency gastrointestinal surgery: 2. Subjects with moderate malnutrition (BML \< 17kg / m2) and severe anemia (HB \< 60g / L): 3. Subject BMI 228kg / m2; 4. Subject platelet (PLT) \< 60x 109 / L or international normalized ratio (INR) \> 1.5; 5. Subject forced expiratory volume per second (FEV1) / expected value ≤ 50%, or forced expiratory volume per second (FEV1) / forced vital capacity (FCV) \< 60%; 6. Subject's cardiac ejection fraction ≤ 50%; 7. Have important organ failure or other serious diseases (e.g. preoperative subject aspartate amino acid) Transferase (AST), or alanine aminotransferase (ALT), or serum creatinine (SER) exceeds normal values Upper limit 3 times and above: subjects with fasting blood glucose value \> 10.0mmol/l before operation: 8. The subjects were pregnant or lactating women; Page 16 of 53 Version No.: 1.1/version date 20190125 Clinical trial on the efficacy and safety of linear cutting stapler and components for disposable electric endoscopy for cutting and anastomosis of gastrointestinal tissue 9. Subjects participated in clinical trials of other drugs or devices within 3 months before the trial; 10. Other conditions that the researchers judged not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anastomosis Success | During surgery | The transection and anastomosis of lung tissues are performed during the operation. The device is withdrawn after successful triggering. The cutting staple line is carefully checked for integrity, air leakage and bleeding. Anastomosis is considered as successful if all anastomotic rings are intact without leakage or bleeding, otherwise it is considered as failure. If necessary, the gas injection method is used to inspect whether there is bubble overflow at anastomotic stoma. If there is no bubble overflow, it is recorded as successful anastomosis; if there is obvious bubble overflow, it is recorded as anastomosis failure. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Disposable Powered Articulating Endoscopic Linear Cutter Stapler Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment | 80 |
| Echelon Flex POWERED Articulating Endoscopic Linear Cutters Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment | 80 |
| Total | 160 |
Baseline characteristics
| Characteristic | Disposable Powered Articulating Endoscopic Linear Cutter Stapler | Echelon Flex POWERED Articulating Endoscopic Linear Cutters | Total |
|---|---|---|---|
| Age, Continuous | 59.16 years STANDARD_DEVIATION 10.85 | 60.40 years STANDARD_DEVIATION 11.06 | 59.78 years STANDARD_DEVIATION 10.94 |
| BMI | 23.00 kg/m2 STANDARD_DEVIATION 2.45 | 22.83 kg/m2 STANDARD_DEVIATION 2.9 | 22.91 kg/m2 STANDARD_DEVIATION 2.68 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment China | 80 participants | 80 participants | 160 participants |
| Sex: Female, Male Female | 23 Participants | 27 Participants | 50 Participants |
| Sex: Female, Male Male | 57 Participants | 53 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 1 / 80 |
| other Total, other adverse events | 65 / 80 | 68 / 80 |
| serious Total, serious adverse events | 11 / 80 | 9 / 80 |
Outcome results
Primary
Number of Participants With Anastomosis Success
The transection and anastomosis of lung tissues are performed during the operation. The device is withdrawn after successful triggering. The cutting staple line is carefully checked for integrity, air leakage and bleeding. Anastomosis is considered as successful if all anastomotic rings are intact without leakage or bleeding, otherwise it is considered as failure. If necessary, the gas injection method is used to inspect whether there is bubble overflow at anastomotic stoma. If there is no bubble overflow, it is recorded as successful anastomosis; if there is obvious bubble overflow, it is recorded as anastomosis failure.
Time frame: During surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Disposable Powered Articulating Endoscopic Linear Cutter Stapler | Number of Participants With Anastomosis Success | 80 Participants |
| Echelon Flex POWERED Articulating Endoscopic Linear Cutters | Number of Participants With Anastomosis Success | 80 Participants |
p-value: <0.0595% CI: [-0.0458, 0.0458]Newcombe-Wilson